Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection

NCT05857163 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: TNP-2198-PO-07
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

A multi-center, randomized, double-blind, bismuth-containing quadruple active comparator-controlled Phase 3 clinical study to evaluate the efficacy and safety of Rifasutenizol in combination with rabeprazole and amoxicillin in the primary treatment of participants with H. pylori infection using an adaptive design with sample size re-estimation.

Conditions

H.Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Eradication Rate of H.Pylori Infection

  The eradication rate of H. pylori is defined as the percentage of participants with negative results of 13C UBT.

  4 to 6 weeks after the last dose of the study drugs

Secondary Outcomes (16)

• Eradication Rate of Antibiotic-resistant Strains of H.Pylori

  4 to 6 weeks after the last dose of the study drugs

• Safety by Assessment of the Number of Participants With Adverse Events (AEs)

  up to 4-6 weeks after the last dose of the study drugs

• Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 1

  Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, and 12 hours after Rifasutenizol (TNP-2198) administration

• Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Rifasutenizol (TNP-2198) on Day 14

  Day 14: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration

• Maximum Observed Plasma Concentration (Cmax) of Rifasutenizol (TNP-2198) on Day 1

  Day 1: 30 minutes before and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 hours after Rifasutenizol (TNP-2198) administration

Study Arms (2)

Test Group

EXPERIMENTAL

Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, twice daily (BID) for 14 days

Drug: Rifasutenizol capsules; Drug: Rabeprazole sodium enteric-coated tablets; Drug: Amoxicillin Capsules; Drug: Clarithromycin placebo tablets; Drug: Bismuth potassium citrate placebo capsules

Control Group

ACTIVE COMPARATOR

Amoxicillin capsules 1 g + Clarithromycin tablets 500 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Bismuth potassium citrate capsules 240 mg + Rifasutenizol placebo capsules, BID for 14 days

Drug: Rabeprazole sodium enteric-coated tablets; Drug: Amoxicillin Capsules; Drug: Clarithromycin tablets; Drug: Bismuth potassium citrate capsules; Drug: Rifasutenizol placebo capsules

Interventions

Rifasutenizol capsules DRUG

400 mg, BID, taken orally within half an hour after breakfast and dinner.

Also known as: TNP-2198 capsules

Test Group

Rabeprazole sodium enteric-coated tablets DRUG

20 mg, BID, taken orally within half an hour before breakfast and dinner.

Also known as: Rabeprazole

Control Group; Test Group

Amoxicillin Capsules DRUG

1 g, BID, taken orally within half an hour after breakfast and dinner.

Also known as: Amoxicillin

Control Group; Test Group

Clarithromycin placebo tablets DRUG

BID, taken orally within half an hour after breakfast and dinner.

Also known as: Clarithromycin placebo

Test Group

Bismuth potassium citrate placebo capsules DRUG

BID, taken orally within half an hour before breakfast and dinner.

Also known as: Bismuth placebo

Test Group

Clarithromycin tablets DRUG

500 mg, BID, taken orally within half an hour after breakfast and dinner.

Also known as: Clarithromycin

Control Group

Bismuth potassium citrate capsules DRUG

240 mg, BID, taken orally within half an hour before breakfast and dinner.

Also known as: Bismuth

Control Group

Rifasutenizol placebo capsules DRUG

BID, taken orally within half an hour before breakfast and dinner.

Also known as: Rifasutenizol placebo

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign the informed consent form.
• Age 18-65 years (inclusive), male or female.
• The result of 13C-UBT is positive (≥ 4 Delta Over Baseline), and the infection of H. pylori are confirmed by gastroscopic biopsy histology.
• Subjects agree to refrain from taking any antibiotics or traditional Chinese medicines with antibacterial effect, bismuth, and antacids (such as proton pump inhibitor, H2 receptor blocker, P-CAB) other than the study drugs during the Screening Period until the end of the study (Visit 5, i.e., Efficacy Evaluation Visit).
• Subjects and their heterosexual partners must agree to have no pregnancy plan and voluntarily take effective contraceptive measures during the trial and for at least 6 months after the end of the study medication.
• Willing to follow and able to complete all trial procedures.

You may not qualify if:

• Allergy to any of the study drugs (rabeprazole, amoxicillin, clarithromycin, bismuth potassium citrate), allergic constitution (multiple drug and food allergies); or any contraindication to the use of rifamycin, nitroimidazoles or study drugs.
• History of H. pylori eradication therapy (including participation in other clinical trials for H. pylori eradication).
• Subjects with confirmed tuberculosis (TB) or Mycobacterium avium complex (MAC) infection or a history of TB or MAC infection.
• History of dysphagia or any gastrointestinal disorder affecting drug absorption.
• History of obstruction pyloric; or excessive gastric acid secretion (such as Zollinger-Ellison syndrome).
• History of gastric cancer.
• History of neoplasm malignant within 5 years prior to screening, with the exception of basal cell carcinoma or carcinoma cervix in situ treated without evidence of recurrence.
• History of esophageal or gastric surgery, except for simple repair of the perforated ulcer.
• History of substance abuse or drug use within 5 years prior to screening.
• Alcohol abuse or a history of alcohol abuse within 5 years prior to screening (average weekly consumption of ≥ 14 units of alcohol: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine/Chinese rice wine/rice wine);
• Presence of active gastric and/or duodenal ulcer.
• Anticoagulant therapy or long-term treatment with nonsteroidal anti-inflammatory drugs.
• Treatment with any other investigational new drugs within 4 weeks prior to the Screening Period.
• Any prohibited medications or non-drug therapies as specified in the protocol (see Section 10.3).
• White blood cell count or neutrophil count below the lower limit of normal range.

Sponsors & Collaborators

• TenNor Therapeutics (Suzhou) Limited: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Related Publications (1)

• Song Z, Zhou L, Wang W, Lan C, Tang T, Xie J, Fan H, Wang X, Zuo X, Zhu Y, Liu C, Gu Y, Feng H, Gao X, Zhang Q, Zhang H, Chen J, Geng G, Ma Z; EVEREST-HP Study Group. Rifasutenizol-based triple therapy versus bismuth plus clarithromycin-based triple therapy for first-line treatment of Helicobacter pylori infection in China (EVEREST-HP): a phase 3, multicentre, randomised, triple-dummy, double-blind, controlled, non-inferiority trial. Lancet Infect Dis. 2026 Jan;26(1):101-110. doi: 10.1016/S1473-3099(25)00438-4. Epub 2025 Sep 10.

  PMID: 40945526 DERIVED

MeSH Terms

Interventions

Rabeprazole; Amoxicillin; Clarithromycin; Bismuth

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals

Results Point of Contact

• Title: Guozhu Geng
• Organization: TenNor Therapeutics (Suzhou) Limited.

guozhu.geng@tennorx.com

0512-86861990

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 12, 2023
• Study Start: May 18, 2023
• Primary Completion: December 24, 2023
• Study Completion: March 26, 2024
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)